Clostridium Difficile InfectionsNCT01957761
Molecular Epidemiology of Clostridium Difficile Infections in Children
An observational study of Clostridium Difficile Infections, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
Objectives: 1. Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area. 2. Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children. 3. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Clostridium Difficile Infections
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Jun 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with Clostridium Difficile infection
Who may be able to join
- Clostridium Difficile infection
Who cannot join
- Age < 1 year
- Age > 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Molecular Epidemiologic Survey and Risk Factor Assessment of Clostridium Difficile Infections in Children: A Focus on Recurrent and Community-associated Infections
Objectives:
- Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area.
- Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children.
- Define the risk factors for recurrent and community-associated Clostridium Difficile infection in children.
- Conditions
- Clostridium Difficile Infections
- Medical subject headings
- Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clostridium difficile infection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis
Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection.
Measured: On day 1 of diagnosis of Clostridium difficile infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clostridium Difficile InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957761
- Sponsor's protocol ID
- Merck MISP 50366
- Status last verified
- Oct 2013
- First submitted
- 19 Nov 2012
- Last updated
- 23 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Epidemiologic Survey and Risk Factor Assessment of Clostridium Difficile Infections in Children: A Focus on Recurrent and Community-associated Infections
- ClinicalTrials.gov ID
- NCT01957761
- Acronym / sponsor ID
- Merck MISP 50366
- Conditions
- Clostridium Difficile Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 23 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- Describe the molecular epidemiology of Clostridium Difficile infection in children in the Chicago area.
- Determine the clinical spectrum and risk factors for Clostridium Difficile infection secondary to particular endemic strains in children.
- Define the risk factors for recurrent and community-associated Clostridium Difficile infection in children.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clostridium difficile infection | – | – |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with Clostridium Difficile infection
Key inclusion criteria (1 listed)
- Clostridium Difficile infection
Key exclusion criteria (2 listed)
- Age < 1 year
- Age > 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis
Time frame: On day 1 of diagnosis of Clostridium difficile infection
Stool samples taken from patients with Clostridium Difficile Infections infection at the time of diagnosis will be assessed by restriction endonuclease analysis to determine strain type. In order to study the relationship between strain type and outcome of their infection (e.g, treatment failure, recurrence, complication of illness), patients will be followed throughout their illness and for 8 weeks after developing their infection.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clostridium Difficile Infections, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clostridium Difficile Infections Strain Type Based on Restriction Endonuclease Analysis (time frame: On day 1 of diagnosis of Clostridium difficile infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.